The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

FDA approves Bimzelx (bimekizumab-bkzx)

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On October 18, 2023, the US Food and Drug Administration approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis  in adults who are candidates for systemic therapy or phototherapy. [1] Bimekizumab is a humanized IgG1 kappa antibody that selectively inhibits IL-17A and IL-17F by binding regions that are common to these pro-inflammatory cytokines, which share ~50% sequence identity and are expressed as homodimers and IL-17A/F heterodimers. Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections of 160 mg each every four weeks to week 16 and every eight weeks thereafter.

The approval of bimekizumab is supported by data from two Phase 3 studies that compared the effects of bimekizumab to those of either ustekinumab (Stellara®; BE VIVID study; NCT03370133) or adalimumab (Humira®; BE SURE study; NCT03412747) in adults with moderate to severe plaque psoriasis. These pivotal studies met their co-primary endpoints at Week 16, demonstrating superiority of bimekizumab over the active comparator in certain defined measures (e.g., Psoriasis Area and Severity Index). Clinical responses achieved with bimekizumab at Week 16 were maintained up to one year. [2-3] Coprimary endpoints were also met in the Phase 3 BE READY study (NCT03410992), which investigated the efficacy and safety of bimekizumab in patients with moderate to severe plaque psoriasis compared to placebo. [4]

  1. UCB. BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis.
  2. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
  3. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
  4. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

Upcoming webinar!

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Registration is open!

Trends in the commercial development of antibody therapeutics: Focus on the early-stage pipeline

Tuesday October 24th, 11am ET/4pm BST/5pm CET

Speaker: Silvia Crescioli, PhD (The Antibody Society)

Need insights into the early-stage antibody therapeutics pipeline? We’ve got you covered! Join us Tuesday Oct 24th for an in-depth analysis of the early-stage pipeline stratified by cancer and non-cancer indications, revealing trends in the molecular formats, targets, and mechanism of action.

Abstract: Since 2014, the number of antibody therapeutics entering clinical development annually has increased steadily, from 71 in 2014 to 286 in 2022. This has resulted in a clinical pipeline currently composed of ~1250 molecules, of which ~1100 and ~150 molecules are in early- and late-stage development, respectively. Despite the great interest in trends in early-stage clinical development, due to the difference in scale and difficulty in tracking molecules newly entered in clinical studies, analyses of trends in the global commercial development of antibody therapeutics are often limited to the late-stage clinical pipeline only. Luckily, The Antibody Society meticulously collects data for antibody therapeutics at all stages of clinical development. This webinar will provide an exhaustive analysis of the early-stage pipeline stratified by cancer and non-cancer indications, revealing trends in the molecular formats, targets, and mechanism of action.

 

 

2023 James S. Huston Antibody Science Talent Award recipient is announced!

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We are delighted to announce that Dr. Heather J. Bax has been selected as the 2023 James S. Huston Antibody Science Talent Award Recipient!

Dr. Heather J. Bax is a Postdoctoral Research Fellow at St John’s Institute of Dermatology, King’s College London. She trained at GlaxoSmithKline as an industrial placement and undergraduate project student supporting drug discovery for asthma and allergic inflammation. She completed her PhD in Professor Hannah Gould’s laboratory, King’s College London, focusing on the interaction between IgE antibodies and mast cells in the context of allergic diseases.

As a Postdoctoral Research Associate in Professor Sophia Karagiannis’ laboratory, King’s College London, Dr. Bax undertook multidisciplinary research on the ground-breaking preclinical development of the first-in-class IgE antibody, MOv18 IgE, for the treatment of folate receptor alpha (FRα)-expressing ovarian cancers. In this role, she established and implemented several clinical trial assays to support the now successfully completed first-in-man, Phase 1 clinical trial of MOv18 IgE (ClinicalTrials.gov Identifier: NCT02546921). She also led the preclinical studies of CSPG4 IgE, another IgE therapeutic candidate targeting melanoma.

Dr. Bax currently supports a translational research program funded by the King’s College London spinout Epsilogen Ltd (formerly IGEM Therapeutics Ltd.), the first immuno-oncology company focusing on IgE immunotherapies for cancer. Leading a team of two postdoctoral researchers and working closely with colleagues at Epsilogen Ltd., she oversees several research studies focusing on the next generation of IgE-based antibodies for the treatment of solid tumors.

The James S. Huston Antibody Science Talent Award is sponsored by The Antibody Society to recognize and encourage upcoming scientists in the field of Antibody Engineering and Therapeutics. Early career research scientists who have received an advanced degree (Ph.D., M.D., or equivalent) within the past ten (10) years are eligible for the Award. The scientist is recognized for making important contributions to the antibody field and/or the dissemination of antibody knowledge. The recipient will be invited to give a lecture on their work, which will be made available on-line on The Antibody Society’s website, and to give a lecture at the Antibody Engineering & Therapeutics conference in December 2023.

The award includes: international recognition of the scientist’s accomplishments, a $1500 USD prize, and travel costs and registration fees to attend the annual Antibody Engineering & Therapeutics conference in San Diego, California.

Reconnect with the AIRR Data Commons: Your Gateway to Immunology Discoveries

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The AIRR Community continues to spearhead innovation in immunology research with the ever-expanding AIRR Data Commons (ADC). For those unfamiliar, the ADC is a pioneering initiative that enables the sharing of standardized Adaptive Immune Receptor Repertoire (AIRR) data. This resource hosts a wealth of information about the diverse array of antibody/B-cell and T-cell receptors that govern immune responses, obtained from bulk and single-cell sequencing technologies. By facilitating the exchange of this valuable data, the ADC enables researchers to gain deeper insights into immunity, disease progression, and therapeutic interventions.

From its inception in 2018 with under 400 million sequence annotations, the ADC has expanded into nine distributed repositories housing 89 studies, over 9800 sample repertoires, and an astonishing 5.2 billion sequence annotations. But this growth is not just about numbers – it’s about fostering collaboration and igniting discoveries. Scientists around the world can access a unified platform to discover, compare, and analyze immunological data, transcending the limitations of individual labs. This interconnectedness not only drives innovation but also eliminates redundancy, saving precious time and resources.

As we look to the future, the ADC is poised to play an even more pivotal role. Its flexible, collaborative framework and continued growth in data will likely attract interdisciplinary partnerships that foster a holistic understanding of the immune system’s complexities. Moreover, the integration of technologies such as machine learning and AI promise to extract deeper insights from the wealth of data, unraveling intricate mechanisms of the immune response.

The AIRR Community’s effort to build and maintain the ADC transcends geographical boundaries and institutional affiliations, exemplifying the spirit of scientific inquiry. As we celebrate the achievements thus far, we eagerly anticipate the advancements that this collaborative endeavor will bring to immunology research in the years to come.

The ADC can be searched interactively using a web user interface at the iReceptor Gateway or VDJServer Community Data Portal. To contribute to the ADC, consider setting up a local repository via the iReceptor Turnkey or submitting data through the VDJServer Community Data Portal.

September Seminar Series

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The September AIRR-C seminar is fast approaching! On September 28th at 7:00 PST/10:00 EST/16:00 CET, Pieter Meysman of the University of Antwerp will be discussing the applications of TCR-epitope prediction models and Felix Drost of Helmholtz Munich will be discussing the prediction of T cell receptor functionality against mutant epitopes.

Register now! The seminar will last approximately 90 minutes.